An observational study in Disorder of Consciousness, Unresponsive Wakefulness Syndrome and Minimally Conscious State, sponsored by BDH-Klinik Hessisch Oldendorf. Not yet recruiting at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by BDH-Klinik Hessisch Oldendorf · Observational
This prospective observational study investigates whether electroencephalography (EEG) can improve the differentiation between unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS) in patients with severe acquired brain injury. The study further examines the association between EEG markers of auditory processing and long-term functional outcome at 12 months.
Accurate classification of disorders of consciousness remains challenging in neurological early rehabilitation. Behavioral assessment is the clinical standard, yet misclassification persists, particularly in patients with severe motor impairment or fluctuating arousal. Neurophysiological measures may provide complementary information beyond observable behavior.
This study applies event-related potential (ERP) paradigms during bedside EEG recording to assess hierarchical levels of auditory processing in patients with disorders of consciousness in the subacute phase after brain injury. The paradigms are designed to detect neural responses reflecting basic auditory discrimination as well as higher-order cognitive processing.
The primary objective is to determine the highest neurophysiologically detectable level of auditory processing and to examine whether it differs between clinically defined consciousness groups. Secondary objectives include evaluating the relationship between EEG-derived markers and standardized behavioral assessments, as well as assessing the prognostic value of EEG findings for functional outcome one year after admission.
The study aims to clarify the diagnostic and prognostic relevance of EEG-based measures in routine neurorehabilitation settings.
290 studies on the registry are indexed under Consciousness Disorders; 109 are open to participants now.
This study's planned enrollment of 42 is below the median of 79 across 95 observational studies indexed under Consciousness Disorders.
Browse Consciousness Disorders studies →BDH-Klinik Hessisch Oldendorf is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
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The study population consists of adult patients (18-80 years) with severe acquired brain injury in the subacute phase who are diagnosed with a disorder of consciousness (Unresponsive Wakefulness Syndrome or Minimally Conscious State) in a neurological rehabilitation setting.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients classified as unresponsive wakefulness syndrome (UWS) with the Coma Recovery Scale-Revised (CRS-R)
Behavioral: Coma Recovery Scale-Revised (CRS-R) · Behavioral: Electroencephalography (EEG)
Patients classified as minimally conscious state (MCS) with the Coma Recovery Scale-Revised (CRS-R)
Behavioral: Coma Recovery Scale-Revised (CRS-R) · Behavioral: Electroencephalography (EEG)
The Coma Recovery Scale-Revised (CRS-R) is a standardized behavioral assessment instrument used to determine the level of consciousness in patients with severe brain injury. It comprises six subscales evaluating auditory, visual, motor, oromotor/verbal, communication, and arousal functions, with hierarchically structured items to identify the highest level of behavioral responsiveness.
Electroencephalography (EEG) is a non-invasive neurophysiological method used to record spontaneous and stimulus-related electrical brain activity via scalp electrodes. In this study, bedside EEG recordings are performed using structured auditory stimulation paradigms designed to elicit event-related potentials (ERPs). These include hierarchical paradigms assessing different levels of auditory processing, ranging from basic sensory discrimination (e.g., mismatch negativity, MMN) to higher-order cognitive processing (e.g., N400 responses). EEG-derived ERP markers are analyzed to determine the highest detectable level of auditory processing and to evaluate their association with clinical diagnosis and long-term functional outcome.
Highest Detectable Hierarchical Level of Auditory Processing
The primary endpoint is the highest neurophysiologically detectable hierarchical level of auditory processing, operationalized by the presence of significant auditory event-related potential (ERP) effects. For each ERP paradigm, analyses are conducted at the individual patient level to determine whether a statistically significant ERP effect is present within predefined time windows and electrode regions. The highest hierarchy level showing a significant effect defines the individual outcome (ordinal scale: levels 1-4).
Time frame: week 2-3 after admission to neurological rehabilitation
Association Between Clinical Level of Consciousness and Neurophysiological Cognitive Processing
Relationship between clinically determined consciousness status (e.g., UWS vs. MCS) and the highest achieved hierarchical level of auditory processing as measured by ERP responses.
Time frame: week 2-3 after admission to neurological rehabilitation
Prognostic Validity of ERP-Based Hierarchical Processing Level
Predictive value of the highest achieved hierarchical level of auditory processing for functional outcome at 12 months after admission. Functional status will be assessed using a standardized outcome measure.
Time frame: 12 months after EEG measurement
Plan to share: No
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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BDH-Klinik Hessisch Oldendorf